SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
seq of the IvDO). Certifications of conformity (CE markings) issued by bodies from EU/EEA coun- tries are unilaterally recognised in Switzerland (Article 25 paragraph 4 of the MedDO and Article 21 paragraph 4 of the IvDO). 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Non-tariff restrictions are set forth in the Swiss customs tariff. The entries in the relevant Har- monised Tariff Schedule (HTS) line will determine which market surveillance authority is compe- tent to examine and approve import. The prod- uct-related laws and implementing ordinances set out the restrictions in detail. 7.5 Trade Blocs and Free Trade Agreements Switzerland is a member of the EFTA and is, among others, signatory to the free trade agree- ment with the EU of 1972 as well as to a net- work of currently 33 free trade agreements with 43 partners. The EU has unilaterally ceased the application of the MRA as regards medical devic- es. As a result, exportation of medical devices from Switzerland into the EU has become more burdensome. Negotiations are currently taking place between Switzerland and the USA on a free trade agreement concerning the pharma- ceuticals sector, which is intended to facilitate market access for Swiss pharma companies. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Under Swiss law, prices of therapeutic products are controlled to the extent that they are reim- bursed by the compulsory health insurance. With regard to therapeutic products not reimbursed
by compulsory health insurance, manufacturers, wholesalers and retailers are, in principle, not restricted in their pricing. Pharmaceuticals are reimbursed subject to a list- ing on the Specialties List (SL) where ready-to- use medicinal products are included. Medicinal products that are manufactured in a pharmacy are reimbursed if their APIs are included in the List of Medicines with Tariff (LMT). The require- ments for price fixing are mainly contained in the HIA, the Health Insurance Ordinance (HIO), and the Ordinance on the Benefits under the Manda- tory Health Insurance (OBHI). The SL determines the ex-factory price as well as the public price, which is the maximum amount (including VAT) that must be reimbursed by health insurers. The FOPH decides on the inclusion of a medici- nal product on the SL after consultation with the Federal Drugs Commission ( Eidgenössis- che Arzneimittelkommission , or EAK), except in the case of certain medicinal products, such as generics and new galenic forms or package siz- es of already-listed medicinal products (Article 31 paragraph 2 lit a of the OBHI). An accelerated procedure applies in the case of an accelerated market authorisation (Article 31a of the OBHI). The procedure is initiated by the market authori- sation holder (Article 31 paragraph 1 lit a of the OBHI). Medicinal products can only be included in the SL if the criteria of efficacy, appropriate- ness and cost-effectiveness are met (Article 32 paragraph 1 of the HIA). The prices are reviewed every three years (Article 65d of the HIO) and additional reviews take place upon patent expiry and in the event of the authorisation of further indications. The List of Items and Tools (LIT) determines which devices are covered by the compulsory health insurance. Unlike the SL, the LIT does not
345 CHAMBERS.COM
Powered by FlippingBook